Effects of Taspoglutide on Glycemic Control and Body Weight in Obese Patients With Type 2 Diabetes (T-Emerge 7 Study)

Objective: Therapies that lower blood glucose and provide weight loss may provide meaningful benefits for obese patients with type 2 diabetes mellitus (T2DM). This study assessed the efficacy of taspoglutide compared with placebo on glycemic control and weight in obese patients with T2DM inadequately controlled with metformin monotherapy. Design and Methods: In a 24-week, randomized, double-blind, placebo-controlled, multicenter trial, obese adults with T2DM were randomized (1: 1) to weekly subcutaneous taspoglutide 20 mg (10 mg for first 4 weeks) (n = 154) or placebo (n = 151) for 24 weeks. Efficacy measures included hemoglobin A1c (HbA1c) levels, body weight, percentage of patients achieving HbA1c <= 6.5 and <= 7.0%, and fasting plasma glucose (FPG). Adverse events (AEs) were assessed. Results: Mean baseline HbA1c was 7.55% and mean baseline BMI was 36.7 kg/m(2). HbA1c reductions from baseline were significantly greater with taspoglutide than placebo (least square mean [LSMean], -0.81% vs. -0.09%; P < 0.0001). Weight loss at week 24 was significantly greater with taspoglutide than placebo (LSMean, -3.16 vs. -1.85 kg; P < 0.01). In the taspoglutide and placebo groups, target HbA1c levels (<= 6.5%) were achieved by 49 and 16% of patients, respectively, while 72 and 36% achieved HbA1c levels <= 7%. Decreases in FPG were significantly greater with taspoglutide than placebo (-23.59 vs. 0.09 mg/dl; P < 0.0001). Nausea and vomiting were the most common AEs associated with taspoglutide, but tended to be transient and generally mild or moderate. Conclusions: In obese patients with T2DM, once-weekly taspoglutide provided the combined benefits of glycemic control and weight loss.